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Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma (QUANARIE)

Primary Purpose

Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electronic PRO in daily clinical practice
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Carcinoma Metastatic focused on measuring Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome, Supportive Care, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with renal clear cells carcinoma, histologically or cytologically confirmed, locally advanced nonresectable or metastatic who initiate an oral treatment by ITK anti-VEGF (Pazopanib or Sunitinib.)
  • Estimated life expectancy over than 3 months.
  • Male or female
  • Aged 18 years or older
  • Patient able to understand French and to complete study questionnaires (no major cognitive disorders)
  • Signed informed consent
  • Patient affiliated to or beneficiary of French social security regime

Exclusion Criteria:

  • Prior systemic treatment for metastatic renal cancer other than immunotherapy. Pretreatment or concomitant treatment with Biphosphonate or Denosumab is allowed.
  • Renal carcinoma without clear cell component.
  • Psychiatric illness compromising understanding of the information or conducting the study.
  • Any acute or chronic disease (eg severe COPD) may affect the patient's ability to receive treatment under study or may make it difficult the interpretation of toxicities or adverse events.
  • HIV positive.
  • History of active chronic hepatitis including subjects who are carriers of Hepatitis B virus or Hepatitis C virus
  • Uncontrolled infection
  • History of digestive pathology which could compromise the good absorption of an oral ITK.
  • Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 4 months from the last treatment administration.
  • Hypersensitivity or contraindication to any of the study drugs (active substance of ITK or any excipients.)

Sites / Locations

  • CHU de Besançon
  • Hôpital privé Sainte MarieRecruiting
  • Centre de lutte contre le cancer Georges François LeclercRecruiting
  • Hôpital Nord Franche-ComtéRecruiting
  • Centre de lutte contre le cancer Jean GodinotRecruiting
  • Groupe hospitaliser St-VincentRecruiting
  • Hôpitaux Universitaires de StrasbourgRecruiting
  • Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de LorraineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Electronic PRO

Arm Description

All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.

Outcomes

Primary Outcome Measures

Rate of filled questionnaires at 12-months
Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.

Secondary Outcome Measures

Exhaustiveness
Number of new cases for each center, initiating a treatment per ITK molecule compared to the number of patients to whom the intervention was proposed
Acceptability
Number of patients who agreed to participate in this study compared to the number of refusals on all patients, by center and by molecule type (Sunitinib or Pazopanib)
Effectiveness
Description of the toxicities collected by physicians according to the NCI CTCAE V4 compared to the toxicities reported by patients according to the 8 symptomatic dimensions of the QLC-C30 questionnaire and 9 items from EORTC Item Bank exploring 6 supplementary symptomatic dimensions
Physician satisfaction

Full Information

First Posted
February 20, 2017
Last Updated
July 24, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03062410
Brief Title
Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma
Acronym
QUANARIE
Official Title
Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
November 4, 2019 (Anticipated)
Study Completion Date
February 4, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL) assessment is often restricted to clinical trial. It could be of particular interest to evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in daily clinical practice of the HRQoL data using standardized questionnaires could strengthen management of symptoms : improve symptom control, improve patient-clinician communication, satisfaction with care and well-being of the patient and in fine the overall survival. The objective of the QUANARIE Study is to assess the use of HRQOL assessment in daily clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using electronic patient reported outcome (PRO). Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to clinicians, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on patient reported outcomet.
Detailed Description
QUANARIE study is an interventional, prospective, multicenter trial involving 9 french oncological centers. Patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer
Keywords
Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome, Supportive Care, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electronic PRO
Arm Type
Other
Arm Description
All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.
Intervention Type
Other
Intervention Name(s)
Electronic PRO in daily clinical practice
Intervention Description
All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.
Primary Outcome Measure Information:
Title
Rate of filled questionnaires at 12-months
Description
Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Exhaustiveness
Description
Number of new cases for each center, initiating a treatment per ITK molecule compared to the number of patients to whom the intervention was proposed
Time Frame
24 months
Title
Acceptability
Description
Number of patients who agreed to participate in this study compared to the number of refusals on all patients, by center and by molecule type (Sunitinib or Pazopanib)
Time Frame
24 months
Title
Effectiveness
Description
Description of the toxicities collected by physicians according to the NCI CTCAE V4 compared to the toxicities reported by patients according to the 8 symptomatic dimensions of the QLC-C30 questionnaire and 9 items from EORTC Item Bank exploring 6 supplementary symptomatic dimensions
Time Frame
24 months
Title
Physician satisfaction
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Time to occurrence of grade 2 toxicity according to the NCI schedule CTCAE v4
Description
Defined as the time elapse between the inclusion date and the date of occurrence of grade 2 toxicity.
Time Frame
24 months
Title
Survival under HRQoL deterioration
Description
Assessed by the QLQ-C30 questionnaire and defined by the time between the inclusion date and the first clinically significant minimal deterioration (MCID) at the baseline score without clinically significant improvement or death from any cause
Time Frame
24 months
Title
Time to treatment failure (TTF)
Description
Defined as the time interval between the date of inclusion and death, tumor progression or definitive cessation of TKI treatment from any cause.
Time Frame
24 months
Title
Progression-free survival (PFS):
Description
Defined as the time interval between the date of inclusion and the date of first progression of the disease or death from any cause.
Time Frame
24 months
Title
Overall Survival (OS):
Description
Defined as the time interval between the date of inclusion and the date of death from any cause.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with renal clear cells carcinoma, histologically or cytologically confirmed, locally advanced nonresectable or metastatic who initiate an oral treatment by ITK anti-VEGF (Pazopanib or Sunitinib.) Estimated life expectancy over than 3 months. Male or female Aged 18 years or older Patient able to understand French and to complete study questionnaires (no major cognitive disorders) Signed informed consent Patient affiliated to or beneficiary of French social security regime Exclusion Criteria: Prior systemic treatment for metastatic renal cancer other than immunotherapy. Pretreatment or concomitant treatment with Biphosphonate or Denosumab is allowed. Renal carcinoma without clear cell component. Psychiatric illness compromising understanding of the information or conducting the study. Any acute or chronic disease (eg severe COPD) may affect the patient's ability to receive treatment under study or may make it difficult the interpretation of toxicities or adverse events. HIV positive. History of active chronic hepatitis including subjects who are carriers of Hepatitis B virus or Hepatitis C virus Uncontrolled infection History of digestive pathology which could compromise the good absorption of an oral ITK. Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 4 months from the last treatment administration. Hypersensitivity or contraindication to any of the study drugs (active substance of ITK or any excipients.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume MOUILLET, MD
Phone
0033370632266
Email
gmouillet@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid POZET
Phone
0033370632179
Email
apozet@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume MOUILLET, MD
Organizational Affiliation
Centre Hospitalier Universitairede Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital privé Sainte Marie
City
Chalon-sur-Saône
ZIP/Postal Code
71100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Viel, MD
Phone
0033385488989
Facility Name
Centre de lutte contre le cancer Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Ladoire, MD
Phone
0033380737506
Email
sladoire@cgfl.fr
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
ZIP/Postal Code
25200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Mouillet, MD
Email
mouillet.guillaume@gmail.com
Facility Name
Centre de lutte contre le cancer Jean Godinot
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Eymard, MD
Facility Name
Groupe hospitaliser St-Vincent
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis-Marie Dourthe, MD
Email
lm.dourthe@solcrr.org
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Barthelemy, MD
Email
philippe.barthelemy@chru-strasbourg.fr
Facility Name
Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionnel Geoffrois, MD
Email
l.geoffrois@nancy.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30717745
Citation
Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.
Results Reference
derived

Learn more about this trial

Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma

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